FDA points security alert on being pregnant exams after bust on unlawful medical lab

A picture of containers taken from the illegal UMI lab in Reedley, California.

Enlarge / An image of containers taken from the unlawful UMI lab in Reedley, California. (credit score: FCDPH)

The Meals and Drug Administration is warning shoppers to not use any at-home exams made by Common Meditech, Inc. (UMI), the corporate behind an unlawful medical lab hidden in a warehouse within the small metropolis of Reedley, California. The lab was shut down earlier this 12 months by native, state, and federal businesses, that are nonetheless working to clear the positioning, correctly eliminate all its hazardous contents, and examine these accountable.

“UMI has notified the FDA that it has stopped all operations and is now not offering help for its exams,” the FDA mentioned in a security communication Friday. “The FDA will not be in a position to verify the efficiency of UMI’s exams, elevating considerations that the exams is probably not protected and efficient.”

UMI manufactured quite a lot of strip-based exams, principally being pregnant exams, but additionally exams for ovulation, ketones, and alcohol in breast milk. The exams have been bought underneath a number of names—together with DiagnosUS, HealthyWiser, DeTec, and PrestiBio. They have been obtainable on-line from a minimum of 4 distributors, which can not have recognized UMI because the producer. The recognized distributors are: AC&C Distribution, LLC; HealthyWiser; House Well being US Inc.; and Status Biotech Inc. The FDA cautions that there could also be different distributors that it does not find out about.

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